McInnis Inc.
Pharmacovigilance and SafetyProvide services relating to adverse event reporting with a focus on the Final Review step of case processing and any other responsibilities typically associated with, but not limited to, the outlines and responsibilities detailed below.
A scalable position requiring 20 - 40 hours per week.
This position is Remote/Telecommute Education:
Must have MD/ DOMust have a Medical license (US or equivalent)Must have at least one year of post-license clinical experience.
Responsibilities of ContractorProvide personnel/resources qualified to meet deliverable expectations as more completely described in the Responsibilities and Deliverables set forth below.
Along with Project Manager, review all timecards and any expense reimbursements for accuracy and adherence with policies.
Patient Safety & Pharmacovigilance Contract Physician Deliverables and
Responsibilities:
Responsible for assessing individual clinical trials and spontaneous case reports for medical review and regulatory reporting determination.
Assessing seriousness, expectedness, and causality.
Querying for additional medical information needed to understand, analyze, and assess the case reports.
Writing individual case assessments.
Interpreting aggregate safety data as needed.
On an as needed basis, perform active phone follow-up on selected medically important cases on behalf of US Patient Safety & Pharmacovigilance (PSPV), in order to optimize safety data collection and analysis.
Scalable position requiring 20 - 40 hours per week.
This position is necessary for GPV to meet its corporate responsibilities to ensure all pharmacovigilance/risk management activities are performed in accordance with standard operating procedures and within regulatory timelines.
Required
Experience:
5 years industry experience in pharmacovigilance/risk management and analysis of safety data.
Clinical Medicine experience with more than 1 year of patient care required.
Excellent written & verbal communication skills.
Experience performing medical review and assessment of individual case safety reports and expedited reporting required.
General knowledge of medical computer programs.
Ability to learn computer database programsOncology experience is highly preferred.
Powered by JazzHRAbout the Company:
McInnis Inc.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
A scalable position requiring 20 - 40 hours per week.
This position is Remote/Telecommute Education:
Must have MD/ DOMust have a Medical license (US or equivalent)Must have at least one year of post-license clinical experience.
Responsibilities of ContractorProvide personnel/resources qualified to meet deliverable expectations as more completely described in the Responsibilities and Deliverables set forth below.
Along with Project Manager, review all timecards and any expense reimbursements for accuracy and adherence with policies.
Patient Safety & Pharmacovigilance Contract Physician Deliverables and
Responsibilities:
Responsible for assessing individual clinical trials and spontaneous case reports for medical review and regulatory reporting determination.
Assessing seriousness, expectedness, and causality.
Querying for additional medical information needed to understand, analyze, and assess the case reports.
Writing individual case assessments.
Interpreting aggregate safety data as needed.
On an as needed basis, perform active phone follow-up on selected medically important cases on behalf of US Patient Safety & Pharmacovigilance (PSPV), in order to optimize safety data collection and analysis.
Scalable position requiring 20 - 40 hours per week.
This position is necessary for GPV to meet its corporate responsibilities to ensure all pharmacovigilance/risk management activities are performed in accordance with standard operating procedures and within regulatory timelines.
Required
Experience:
5 years industry experience in pharmacovigilance/risk management and analysis of safety data.
Clinical Medicine experience with more than 1 year of patient care required.
Excellent written & verbal communication skills.
Experience performing medical review and assessment of individual case safety reports and expedited reporting required.
General knowledge of medical computer programs.
Ability to learn computer database programsOncology experience is highly preferred.
Powered by JazzHRAbout the Company:
McInnis Inc.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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